7th HEALTH CARE ADDON CONFERENCE

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7th HEALTH CARE ADD-ON CONFERENCE May 2
2002 Mayflower Hotel, Washington, DC
Brian R. Stanton Technology Center
1600 Biotechnology, Organic Chemistry
Pharmaceuticals
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Topics Du Jour

• Legislative and Case Law Background
• A Quick Ride from 1793 to Present
• Utility Guidelines
• What makes something useful?
• Written Description Guidelines
• Ensuring Possession

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Cam / Ottawa Citizen - - Used with permission
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ConstitutionArticle I, Section 8, Clause 8

• The Constitution grants Congress broad power to
  legislate to promote the progress of science and
  the useful arts, by securing for limited times to
  authors and inventors the exclusive right to
  their respective writings and discoveries.

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35 U.S.C. 101Inventions Patentable

• Whoever invents or discovers any new and useful
  process, machine, manufacture, or composition of
  matter, or any new and useful improvement
  thereof, may obtain a patent therefor, subject to
  the conditions and requirements of this title.

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P.J. Federico

• Under section 101 a person may have invented a
  machine or manufacture, which may include
  anything under the sun that is made by man.

Hearing on H.R. 3760 before Subcommittee No. 3 of
the House Committee on the Judiciary, 82d Cong.,
1st Sess., 37 (1951)
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Diamond v. Chakrabarty

• The fact that Congress contemplated that patent
  laws would be given wide scope is not to suggest
  that Section 101 has no limits or that it
  embraces every discovery since laws of nature,
  physical phenomena, and abstract ideas have been
  held not patentable, new mineral discovered in
  earth or new plant found in wild is not
  patentable subject matter likewise, Einstein
  could not patent his celebrated law that Emc2
  nor could Newton have patented law of gravity
  such discoveries, which are manifestations of
  nature are free to all men and reserved
  exclusively to none.

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Court Consideration

• Potential hazards of genetic research should not
  be weighed in considering whether invention of
  microorganisms is patentable subject matter under
  Section 101 Supreme Court is without competence
  to entertain such arguments, either to brush them
  aside as fantasies generated by fear of unknown
  or to act on them whatever their validity, such
  contentions should be addressed to political
  branches of government, Congress and Executive,
  and not the courts.
• Diamond v. Chakrabarty 447 U.S. 303, 316-317

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Diamond v. ChakrabartyUtility Determination

• respondents micro-organism plainly qualifies
  as patentable subject matter. His claim is not
  to a hitherto unknown natural phenomenon, but to
  a nonnaturally occurring manufacture or
  composition of matter -- a product of human
  ingenuity having a distinctive name, character
  and use. 447 U.S. 303, 309-310
• His discovery is not natures handiwork, but his
  own accordingly it is patentable subject matter
  under 101. 447 U.S. 303, 317

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Diamond v. Chakrabarty

• The choice we are urged to make is a matter of
  high policy for resolution within the legislative
  process after the kind of investigation,
  examination, and study that legislative bodies
  can provide and courts cannot. That process
  involves the balancing of competing values and
  interests, which in our democratic system is the
  business of elected representatives. 447 U.S.
  303, 317

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Ex parte Hibberd227 USPQ 443, (Bd. App. Int.
1985)

• The Board, referring to Diamond v. Chakrabarty,
  447 U.S. 303, 206 USPQ 193 (1980), said
• The court noted that the use of the expansive
  terms manufacture and composition of matter
  modified by the comprehensive any intended that
  Congress plainly contemplated that the patent
  laws would be given wide scope.227 USPQ 443, 444

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Cam / Ottawa Citizen - - Used with permission
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Ex parte Allen2 USPQ2d 1425 (Bd. Pat. App.
Interf. 1988)

• Examiners Position
• . . . the animal produced by the method claimed
  is controlled by laws of nature and not a
  manufacture by man that is patentable. 2 USPQ2d
  1425, 1426
• Board of Patent Appeals and Interferences
• The examiners position that the claimed
  polyploid oysters are held to be living
  entities is not controlling on the question of
  whether the claims are drawn to patentable
  subject matter under 35 USC 101 because the
  Supreme Court made it clear in Diamond v.
  Chakrabartythat Section 101 includes man-made
  life forms. 2 USPQ2d 1425, 1427.

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Ex parte Allen

• The examiner has presented no evidence that the
  claimed polyploid oysters occur naturally without
  the intervention of man, nor has the examiner
  urged that polyploid oysters occur naturally.
  The record before us leads to no conclusion other
  than that the claimed polyploid oysters are
  non-naturally occurring manufactures or
  compositions of matter within the confines of
  patentable subject matter under 35 USC 101.
• 2 USPQ2d 1425, 1427.

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Cam / Ottawa Citizen - - Used with permission
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Juicy Whip Inc. v. Orange Bang Inc.185 F.3d
1364, 51 USPQ2d 1700 (Fed. Cir. 1999)

• Patent for post-mix beverage dispenser with
  display reservior containing liquid that
  simulates appearance of dispensed beverage . . .
• . . . even if use of reservoir containing fluid
  that is not dispensed is considered deceptive . .
  .

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Juicy Whip Inc. v. Orange Bang Inc.185 F.3d
1364, 51 USPQ2d 1700 (Fed. Cir. 1999)

• The court concluded that the invention lacked
  utility because
• the purpose was to increase sales by deception
• it confers no benefit other than to make a
  product more salable
• it merely imitates a pre-mix dispenser and thus
  is not a new and useful machine

U.S. District Court for the Central District of
California
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Juicy Whip Inc. v. Orange Bang Inc.185 F.3d
1364, 51 USPQ2d 1700 (Fed. Cir. 1999)

• It is not unusual for a product to be designed
  to appear to be something it is not. For example,
  cubic zirconium . . ., imitation gold leaf . . .,
  and imitation leather . . . In each case, the
  invention of the product or process that makes
  such imitation possible has utility within the
  meaning of the patent statute . . .
• Moreover, even if the use of a reservoir
  containing fluid that is not dispensed is
  considered deceptive, that is not by itself
  sufficient to render the invention unpatentable.
  

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Juicy Whip Inc. v. Orange Bang Inc.185 F.3d
1364, 51 USPQ2d 1700 (Fed. Cir. 1999)

• The requirement of utility in patent law is
  not a directive to the Patent and Trademark
  Office or the courts to serve as arbiters of
  deceptive trade practices. Other agencies, such
  as the Federal Trade Commission and the Food and
  Drug Administration, are assigned the task of
  protecting consumers from fraud and deception in
  the sale of food products. 185 F.3d 1364, 1368.

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Utility Guidelines

• Federal Register
• http//www.access.gpo.gov/su_docs/aces/aces140.htm
  l
• Utility Guidelines
• 66 FR 1092 (January 5, 2001)
• USPTO Web Site
• http//www.uspto.gov
• Examiner Training Examples
• Applies to all pending applications

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What Makes Something Useful?

• Three-pronged
• Specific
• Substantial
• Credible

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Specific Utility - Definition

• A utility that is specific to the subject matter
  claimed. This contrasts with a general utility
  that would be applicable to the broad class of
  the invention.
• For example, a claim to a polynucleotide whose
  use is disclosed simply as a gene probe or
  chromosome marker would not be considered to be
  specific in the absence of a disclosure of a
  specific DNA target. Similarly, a general
  statement of diagnostic utility, such as
  diagnosing an unspecified disease, would
  ordinarily be insufficient absent a disclosure of
  what condition can be diagnosed.

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Substantial Utility - Definition

• A utility that defines a "real world" use.
• Utilities that require or constitute carrying out
  further research to identify or reasonably
  confirm a "real world" context of use are not
  substantial utilities.

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Substantial Utility Real World Examples

• Both a therapeutic method of treating a known or
  newly discovered disease and an assay method for
  identifying compounds that themselves have a
  "substantial utility" define a "real world"
  context of use.
• An assay that measures the presence of a material
  which has a stated correlation to a
  predisposition to the onset of a particular
  disease condition would also define a "real
  world" context of use in identifying potential
  candidates for preventive measures or further
  monitoring.

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Substantial UtilityWannaBe Real World Examples

• The following are examples of situations that
  require or constitute carrying out further
  research to identify or reasonably confirm a
  "real world" context of use and, therefore, do
  not define "substantial utilities"
• A. Basic research such as studying the
  properties of the claimed product itself or the
  mechanisms in which the material is involved.
• B. A method of treating an unspecified disease
  or condition. (Note, this is in contrast to the
  general rule that treatments of specific diseases
  or conditions meet the criteria of 35 U.S.C.
  101.)
• C. A method of assaying for or identifying a
  material that itself has no "specific and/or
  substantial utility".
• A method of making a material that itself has no
  specific, substantial and credible utility.
• A claim to an intermediate product for use in
  making a final product that has no specific,
  substantial and credible utility.

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Substantial UtilityThrow Away

• Note that throw away utilities do not meet the
  tests for a specific or substantial utility.
• For example, using transgenic mice as snake food
  is a utility that is neither specific (all mice
  could function as snake food) nor substantial
  (using a mouse costing tens of thousands of
  dollars to produce as snake food is not a real
  world context of use).
• Similarly, use of any protein as an animal food
  supplement or a shampoo ingredient are throw
  away utilities that would not pass muster as
  specific or substantial utilities under 35 U.S.C.
  101.
• This analysis should be tempered by consideration
  of the context and nature of the invention.
• If a transgenic mouse was generated with the
  specific provision of an enhanced nutrient
  profile, and disclosed for use as an animal food,
  then the test for specific and substantial
  asserted utility would be considered to be met.

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Substantial Utility Wheel
Nucleic Acid
Protein
Probe for disease state e.g. cancer gene mutation
Assay for specific, substantial, credible use
Antibody
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Credible Utility - Definition

• An assertion is credible unless
• (A) the logic underlying the assertion is
  seriously flawed, or
• (B) the facts upon which the assertion is based
  are inconsistent with the logic underlying the
  assertion.
• Credibility as used in this context refers to the
  reliability of the statement based on the logic
  and facts that are offered by the applicant to
  support the assertion of utility.
• A credible utility is assessed from the
  standpoint of whether a person of ordinary skill
  in the art would accept that the recited or
  disclosed invention is currently available for
  such use.
• For example, no perpetual motion machines would
  be considered to be currently available.
  However, nucleic acids could be used as probes,
  chromosome markers, or forensic or diagnostic
  markers.

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Well Established UtilitiesDefinition

• A specific, substantial, and credible utility
  which is well known, immediately apparent, or
  implied by the specifications disclosure of the
  properties of a material, alone or taken with the
  knowledge of one skilled in the art.
• "Well established utility" does not encompass any
  "throw away" utility that one can dream up for an
  invention or a nonspecific utility that would
  apply to virtually every member of a general
  class of materials, such as proteins or DNA.

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Written Description Guidelines

• Federal Register
• (http//www.access.gpo.gov/su_docs/aces/aces140.ht
  ml)
• Utility Guidelines
• 66 FR 1092 (January 5, 2001)
• USPTO Web Site
• http//www.uspto.gov
• Examiner Training Examples
• Applies to all pending applications

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Coverage

• Written in technology neutral manner since recent
  decisions of the Federal Circuit have written
  description implications in a broad range of
  technologies
• Eli Lilly Co. Tronzo v. Biomet, Inc., 156 F.3d
  1154, 47 USPQ2d 1829 (Fed. Cir. 1998) Gentry
  Gallery, Inc. v. Berkline Corp., 134 F.3d 1473,
  45 USPQ2d 1498 (Fed. Cir. 1998) Union Oil Co. of
  Cal. v. Atlantic Richfield Co., 99-1066 (Fed.
  Cir., March 29, 2000).
• Products, Processes, Products by Process

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General Principles

• Basic inquiry Can one skilled in the art
  reasonably conclude that the inventor was in
  possession of the claimed invention at the time
  the application was filed?
• Written description requirement is separate and
  distinct from the enablement requirement

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QUESTIONS ???
DNA
Proteins
ESTs
SNPs
Chimera